# QGM: Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation

- Device class: 2; regulation: 21 CFR 878.4405; FDA's rule: 510(k) required
- FDA decisions: 3
- 510(k) review time 2021–2025: median 131 days (middle half 126–136)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2023: 1
- 2024: 2

## Most-cited predicates
- DEN220087: Edison System (2023), cited by 1
- K233466: Edison System (2024), cited by 1

Source page: https://510kreport.com/product-code/QGM
Data by year (CSV): https://510kreport.com/product-code/QGM.csv